510(k) · Cleared
ClearedProcera All-Ceramic Porcelain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · EIH Powder, Porcelain
Cleared on Dec 2, 1994 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 2, 1994
- Review
- 71 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK944702 Procera All-Ceramic PorcelainNobelpharma USA, Inc. · 1994
- Descendant · cites it directly · 4 of its ownK041312 Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK043312 Nobelrondo Dental Ceramic - ZirconiaNobel Biocare USA, LLC · 2005
- Descendant · 3 generations on · 2 of its ownK140848 Luminesse Porcelain SystemTalladium, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK182350 Dental CeramicBaot Biological Technology Co., Ltd. · 2019
- Descendant · 4 generations on · 0 of its ownK163251 Life Essence Universal Porcelain SystemBlue Sky Bio · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041312Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004 · cites it directly4descendants
- K043312Nobelrondo Dental Ceramic - ZirconiaNobel Biocare USA, LLC · 2005 · 2 generations on3descendants
- K140848Luminesse Porcelain SystemTalladium, Inc. · 2014 · 3 generations on2descendants
- K182350Dental CeramicBaot Biological Technology Co., Ltd. · 2019 · 4 generations on0descendants
- K163251Life Essence Universal Porcelain SystemBlue Sky Bio · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944702 | Procera All-Ceramic Porcelain | Nobelpharma USA, Inc. | 1994 | — |
| +1 | K041312 | Nobelrondo Dental Ceramic-Alumina | Nobel Biocare Uas, Inc. | 2004 | — |
| +2 | K043312 | Nobelrondo Dental Ceramic - Zirconia | Nobel Biocare USA, LLC | 2005 | — |
| +3 | K140848 | Luminesse Porcelain System | Talladium, Inc. | 2014 | — |
| +4 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | 2019 | — |
| +4 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041312 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
https://510kreport.com/device/K944702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944702: Procera All-Ceramic Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944702
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026